1. Field of the Invention
The present disclosure relates to certain low dose forms of weight-based dosing of minocycline, preferably minocycline hydrochloride, in a slow, continuous or extended release delivery vehicle to form oral dosage units that provide for the effective treatment of acne with reduced or almost negligible side effects. The present disclosure also relates to the method for treating acne with reduced or almost negligible side effects by the use of such dosage forms based on a person's weight.
2. Description of the Related Art
Acne affects large patient populations, and is a common inflammatory skin disorder that usually localizes in sebaceous areas of the body, including on the face, back and chest.
Oral tetracycline-class antibiotics are frequently used in the treatment of acne. Tetracycline-class antibiotics are known to have some side effects. These side effects include vestibular side effects or symptoms such as vertigo, dizziness or blurred vision. These effects are sometimes disabling. See, Gould & Brookler, Arch. Otolarang. Vol. 96, p. 291 (1972); Williams et al., Lancet, Sep. 28, 1974, p. 144-45; Fanning & Gump, Arch. Intern. Med., Vol. 136, pp. 761-62 (1976). Headache and general malaise, along with gastrointestinal symptoms such as the diarrhea, nausea, gas, or cramps, may also occur. Dry nose and dry mouth are also occasionally encountered.
One oral tetracycline-class antibiotic used in the treatment of acne is minocycline hydrochloride. Oral dosage forms of minocycline hydrochloride are available commercially under various trade names.
The dosing schedule used most frequently for treating acne using currently available immediate-release oral dosage forms is 100 mg of minocycline (free base equivalent) administered twice daily, see Leyden, J. Cutis 2006; 78 (suppl 4):4-5. However, some patients experience adverse effects with currently available immediate-release oral dosage forms, leading to reduced rates of patient compliance. See Stewart, M. et al., Cutis 2006; 78 (suppl 4):11-20.
Although the development of slowly dissolving forms of minocycline hydrochloride was a significant advance in the art, there remains a long-felt need for treatments that are effective in suppressing acne but are associated with fewer adverse effects than those associated with the various oral dosage forms of minocycline hydrochloride. Such a need is addressed in the present assignees corresponding pending applications that address weight based dosing, as well as certain commercial 45/90/135 mg dose forms.